Clinical Trial: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

Brief Summary: The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

Detailed Summary:

This is a randomized, controlled, multi‐center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.


Sponsor: Valneva Austria GmbH

Current Primary Outcome: GMT for Anti-JEV Neutralizing Antibody [ Time Frame: day 56 ]

Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.


Original Primary Outcome: Geometric Mean Titers for anti-JEV neutralizing antibody

Current Secondary Outcome:

  • Safety [ Time Frame: study duration ]
    Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
  • SCR for Anti-JEC Neutralizing Antibody Titer [ Time Frame: day 56 ]


Original Secondary Outcome: Safety and Adverse Events

Information By: Valneva Austria GmbH

Dates:
Date Received: January 4, 2008
Date Started: September 2006
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016